NCT01233323已完成不适用
Detection of Phrenic Nerve Stimulation Using Accelerometer and Electrogram Signals Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Data collection
研究概览
简要总结
The purpose of this study is to collect sensor data from patients with implanted cardiac resynchronization devices who exhibit phrenic nerve stimulation.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing and capable of providing informed consent and of participating in all testing
- •Age 18 or above or of legal age to give informed consent specific to national law
- •Implanted with a Boston Scientific COGNIS™ family device
- •Geographically stable and is available for follow-up procedures at a study centre
排除标准
- •Patients that are pacemaker-dependent
- •Women who are pregnant or plan to become pregnant during the study (method of assessment upon physician's discretion)
- •Patients who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the patient is participating in a mandatory governmental registry
- •Patients who are not expected to support approximately 30 minutes of study testing procedures
- •Patients who are not mentally competent enough to provide feedback on PS during study procedures
结局指标
主要结局
Data collection
时间窗: 3 months follow up
Collect sensor data in patients with implanted CRT-D devices who exhibit phrenic nerve stimulation.
次要结局
未报告次要终点
研究者
研究点 (1)
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